The following data is part of a premarket notification filed by Neotract, Inc. with the FDA for Neotract Anchor System Model Tas400.
| Device ID | K102028 |
| 510k Number | K102028 |
| Device Name: | NEOTRACT ANCHOR SYSTEM MODEL TAS400 |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
| Contact | Kevin F Macdonald |
| Correspondent | Kevin F Macdonald NEOTRACT, INC. 4473 WILLOW ROAD SUITE 100 Pleasanton, CA 94588 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-19 |
| Decision Date | 2010-08-04 |
| Summary: | summary |